Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Background: Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality among patients with heart failure and reduced ejection fraction, but their efficacy in those with heart failure and mildly reduced or preserved ejection fraction has not been established. Data regarding the efficacy and safety of the nonsteroidal mineralocorticoid receptor antagonist finerenone in patients with heart failure and mildly reduced or preserved ejection fraction are needed. Methods: In this international, double-blind trial, we randomly assigned patients with heart failure and a left ventricular ejection fraction of 40% or greater, in a 1:1 ratio, to receive finerenone (at a maximum dose of 20 mg or 40 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes. The components of the primary outcome and safety were also assessed. Results: Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients in the finerenone group, and 1283 primary-outcome events occurred in 719 of 2998 patients in the placebo group (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). The total number of worsening heart failure events was 842 in the finerenone group and 1024 in the placebo group (rate ratio, 0.82; 95% CI, 0.71 to 0.94; P = 0.006). The percentage of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Finerenone was associated with an increased risk of hyperkalemia and a reduced risk of hypokalemia. Conclusions: In patients with heart failure and mildly reduced or preserved ejection fraction, finerenone resulted in a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes than placebo. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.).
14.09.2020 – 14.06.2024 AHMET ÇELİK
Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes
Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes. Whether semaglutide can reduce cardiovascular risk associated with overweight and obesity in the absence of diabetes is unknown. METHODS In a multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial, we enrolled patients 45 years of age or older who had preexisting cardiovascular disease and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 27 or greater but no history of diabetes. Patients were randomly assigned in a 1:1 ratio to receive once-weekly subcutaneous semaglutide at a dose of 2.4 mg or placebo. The primary cardiovascular end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in a time-to-first-event analysis. Safety was also assessed. RESULTS A total of 17,604 patients were enrolled; 8803 were assigned to receive semaglutide and 8801 to receive placebo. The mean (±SD) duration of exposure to semaglutide or placebo was 34.2±13.7 months, and the mean duration of follow-up was 39.8±9.4 months. A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; 95% confidence interval, 0.72 to 0.90; P<0.001). Adverse events leading to permanent discontinuation of the trial product occurred in 1461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001). CONCLUSIONS In patients with preexisting cardiovascular disease and overweight or obesity but without diabetes, weekly subcutaneous semaglutide at a dose of 2.4 mg was superior to placebo in reducing the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke at a mean follow-up of 39.8 months. (Funded by Novo Nordisk; SELECT ClinicalTrials.gov number, NCT03574597. opens in new tab.)
24.10.2018 – 29.06.2023 AHMET ÇELİK
Global Congestive Heart Failure (G-CHF) Registry
Frailty and outcomes in heart failure patients from high-, middle-, and low-income countries
01.01.2019 – 01.06.2023 AHMET ÇELİK
PCHF-COVICAV registry
16.05.2020 – 08.12.2021 AHMET ÇELİK
Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial
10.08.2016 – 01.06.2021 AHMET ÇELİK
Düşük Ejeksiyon Fraksiyonlu Kronik Kalp Yetmezliği Olan Hastalarda Omekamtiv Mekarbilin Mortalite ve Morbidite Üzerindeki Etkililiğini ve Güvenliliğini Değerlendirmeye Yönelik Çift Kör, Randomize, Plasebo Kontrollü, Çok Merkezli Bir Çalışma” GALACTIC HF çalışması
22.12.2016 – 16.01.2021 AHMET ÇELİK, LÜTFÜ BEKAR
Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Background: The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. Methods: We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes.
11.10.2016 – 13.11.2020 AHMET ÇELİK
VICTORIA- Vericiguat in Patients with Heart Failure and Reduced Ejection
FractionBackground: The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear. Methods: In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
10.08.2016 – 14.07.2020 AHMET ÇELİK
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure (COMMANDER HF)
MERSİN ÜNİVERSİTESİ 14.06.2013 – 08.08.2018 AHMET ÇELİK
TURKish acute myocardial infarction registry: The TURKMI Study
TURKMI kayıt çalışması, Türkiye’xxde akut miyokart infarktüsü (Mİ) hastalarının özellikleri, semptoların başlamasından hastaneden taburcu olunmasına kadarki tedavi yöntemleri ve sonuçları hakkında bilgi edinmek için tasarlanmıştır.
01.11.2018 – MEHMET İNANIR, LATİFE MERAL KAYIKÇIOĞLU, MUSTAFA KILIÇKAP, MUSTAFA KEMAL EROL, Ömer Genç, Abdullah Yıldırım, Ramazan Aşoğlu, Mustafa Çetin, Emrullah Kızıltunç, Ahmet Göktuğ Ertem, Mehmet Kadri Akboğa, Ahmet Genç, Gülsüm Meral Yılmaz Öztekin, Mesut Gitmez, Burcu Tuncay, Veysi Can, Hasan arı, Fatih Paşa Tatar, Cuma Yeşildaş, okan er, Önder Öztürk, Çetin Mirzaoğlu, orhan ince, Emirhan Hancıoğlu, İbrahim Faruk Akürk, ersan Oflar, nihan Turhan Çağlar, Hatice Aylin Yamaç Halaç, Muhsin Kalyoncuoğlu, İsmail Balaban, mesut Karataş, Arda Güler, Cemil Can, Ardacan Doğan, Ahmet Arif Yalçın, Can Baba Arın, Murat Küçükokur, Hakan Güneş, Eyüp Özkan, Cengiz Şabanoğlu, Yunus Çelik, İbrahim Aktaş, Gökhan Gözübüyük, nuri Köse, Ahmet Yanık, Mustafa Yenerçağ, Ömer Faruk Çıtrakoğlu, Sadettin Selçuk baysal, Nesim Aladağ, Remzi Sarıkaya, Ramazan Düz, Haşim Tüner, İsmail Ünğan, Bilge Duran Karaduman, Engin Bozkurt, ENDER ÖRNEK, ÖNER ÖZDOĞAN, İBRAHİM HALİL KURT, AYÇA ARSLAN, MEHMET ALİ ASTARCIOĞLU, SERVET ALTAY, TANER ŞEN, YILMAZ GÜNEŞ, AYTAÇ CANDEMİR, UTKU ZEYBEY, CEVAT KIRMA, MUSTAFA UMUT SOMUNCU, EKREM AKSU, OSMAN YASİN YALÇIN, İBRAHİM KOCAYİĞİT, İHSAN DURSUN, NADİR EMLEK, AHMET ÇELİK, OĞUZ YAVUZGİL, ZİYA ŞİMŞEK, EMİNE GAZİ, ÜMİT YAŞAR SİNAN, OĞUZ AKKUŞ, ÇAĞRI YAYLA, YAKUP ALSANCAK, İSMAİL DOĞU KILIÇ, FEYZULLAH BEŞLİ, MUHAMMET DURAL, KADİR UĞUR MERT, SİNAN İNCİ, MURAT SÜNBÜL, MUSTAFA KÜRŞAT TİGEN, EFTAL MURAT BAKIRCI, ONUR SİNAN DEVECİ, HÜSNÜ DEĞİRMENCİ, MUSTAFA TUNCER
SAĞLIK BAKANLIĞI ULUSAL KALP YETERSİZLİĞİ ÇALIŞMASI- TRENDS-HF REGISTRY
TÜRKİYEDE 85 MİLYON VATANDAŞIN KALP YETERSİZLİĞİ PREVELANSINI İNSİDANSI VE MORTALİTE VERİLERİNİ SAPTAMAK
01.01.2023 – 31.12.2023 AHMET ÇELİK
TURKish Acute Myocardial Infarction Registry (TURKMI)
TURKMI kayıt çalışması, Türkiye’de akut miyokard infarktüsü (MI) hastalarının özellikleri, semptomların başlamasından hastaneden taburcu olunmasına süreçteki kadarki tedavi yönetimleri ve sonuçları hakkında bilgi edinmek için tasarlanmıştır. Sonuçlara ulaşmak için, Türkiye’nin her bölgesinden, nüfus yoğunluğu göz önünde bulundurularak seçilen 50 merkezden gelen veriler kullanılmıştır.
01.01.2018 – 12.03.2020 MUSTAFA KEMAL EROL, LATİFE MERAL KAYIKÇIOĞLU, MUSTAFA KILIÇKAP, MEHMET İNANIR, MUSTAFA UMUT SOMUNCU, OSMAN YASİN YALÇIN, YILMAZ GÜNEŞ, İBRAHİM HALİL KURT, Ömer Genç, Abdullah Yıldırım, Ramazan Aşoğlu, ENDER ÖRNEK, Mustafa Çetin, EMRULLAH KIZILTUNÇ, ÇAĞRI YAYLA, Ahmet Göktuğ Ertem, MEHMET KADRİ AKBOĞA, Ahmet Genç, Gülsüm Meral Yılmaz öztekin, Mesut Gitmez, Burcu Tuncay, Veysi Can, Hasan Arı, fatih Paşa tatar, EMİNE GAZİ, CUMA YEŞİLDAŞ, ONUR SİNAN DEVECİ, Okan Er, Önder Öztürk, AYTAÇ CANDEMİR, OĞUZ YAVUZGİL, ÇETİN MİRZAOĞLU, EFTAL MURAT BAKIRCI, HÜSNÜ DEĞİRMENCİ, FEYZULLAH BEŞLİ, ORHAN İNCE, EMİRHAN HANCIOĞLU, İBRAHİM FARUK AKTÜRK, ERSAN OFLAR, NİHAN TURHAN ÇAĞLAR, HATİCE AYLİN YAMAÇ HALAÇ, MUHSİN KALYONCUOĞLU, İSMAİL BALABAN, MESUT KARATAŞ, CEVAT KIRMA, ARDA GÜLER, CEMİL CAN, ARDA CAN DOĞAN, AHMET ARİF YALÇIN, CAN BABA ARIN, ÜMİT YAŞAR SİNAN, MURAT KÜÇÜKOKUR, ÖNER ÖZDOĞAN, EMRE AKSU, HAKAN GÜNEŞ, ZİYA ŞİMŞEK, EYÜP ÖZKAN, CENGİZ ŞABANOĞLU, YUNUS ÇELİK, YUNUS ÇELİK, TANER ŞEN, MEHMET ALİ ASTARCIOĞLU, İBRAHİM AKTAŞ, GÖKHAN GÖZÜBÜYÜK, MUSTAFA KÜRŞAT TİGEN, MURAT SÜNBÜL, AYÇA ARSLAN, AHMET ÇELİK, OĞUZ AKKUŞ, YAKUP ALSANCAK, MUHAMMET DURAL, KADİR UĞUR MERT, NURİ KÖSE, İSMAİL DOĞU KILIÇ, NADİR EMLEK, İBRAHİM KOCAYİĞİT, AHMET YANIK, MUSTAFA YENERÇAĞ, ÖMER FARUK ÇITRAKOĞLU, İHSAN DURSUN, UTKU ZEYBEY, SERVET ALTAY, SADETTİN SELÇUK BAYSAL, NESİM ALADAĞ, REMZİ SARIKAYA, RAMAZAN DÜZ, MUSTAFA TUNCER, HAŞİM TUNER, İSMAİL UNGAN, BİLGE DURAN KARADUMAN, ENGİN BOZKURT
Snapshot Evaluation of Acute and Chronic Heart Failure in Real Life in Turkey (SELFIE-TR)
MERSİN ÜNİVERSİTESİ 01.10.2015 – 01.01.2018 AHMET ÇELİK
Acute and Chronic Heart Failure in Real Life in Turkey: National, Multi-center, Epidemiological, Observational and Ad-Hoc Cross-sectional StudySnapshot Evaluation of Heart Failure in Turkey: Initial Analysis from SELFIE-TR
Primary Outcome Measures :Survival in patients with acute and chronic heart failure [ Time Frame: 1 year after the enrollment is over ]Patients with acute and chronic heart failure will be contacted via telephone call at least 1 year after the enrollment to see their survival status and cardiovascular mortality rates will be calculated as an outcome measure and will be compared (acute versus chronic).Secondary Outcome Measures :Guideline directed heart failure medications and outcome [ Time Frame: Prospective data collection during follow up ]Prescription records of patients will be obtained and patients will be classified into two as those with and those without specific prescribed medication, and then these findings will be related to cardiovascular mortalityCo-morbidities and outcome [ Time Frame: Prospective survival data collection during follow up ]Records of patients with regard to existing co-morbidities during index event will be collected and then be related to cardiovascular mortality during follow up.
01.10.2015 – 01.06.2017 NESLİGÜL YILDIRIM, MEHMET BİRHAN YILMAZ, LÜTFÜ BEKAR, AHMET TEMİZHAN, AHMET ÇELİK, ERSEL ONRAT, ORHAN DOĞDU, HASAN GÜNGÖR, PINAR KIZILIRMAK, SADBERK LALE TOKGÖZOĞLU